Colorectal Cancer MetastaticNCT07917429
Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC
An observational study of Colorectal Cancer Metastatic, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
This is a prospective, observational, multicenter cohort study. Subjects will be divided into the Panitumumab N01 group (experimental group) and the cetuximab or cetuximab N01 group (control group) according to the treatment they actually receive. Both groups will receive FOLFOX chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Panitumumab N01 and Cetuximab (EGFR inhibitor)
- How many people
- 610 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 1 Jun 2030
- How long will I take part?
- 30 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First-line RAS wild-type metastatic colorectal cancer patients
Who may be able to join
- Aged ≥ 18 years, regardless of gender.
- Histopathologically and radiologically-confirmed metastatic colorectal cancer with RAS wild-type status (wild-type for KRAS and NRAS exons 2, 3 and 4; if test records are limited, the exact test scope and testing method should be documented); and the participant is planned to receive FOLFOX combined with either Panitumumab N01 or cetuximab/cetuximab N01.
- At least one measurable lesion assessable per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- No prior anti-tumor therapy for colorectal cancer, including chemotherapy, radiotherapy, targeted agents, surgery and immunotherapy. Participants with disease recurrence and metastasis > 3 months after completion of adjuvant chemotherapy or prior local treatment of the primary lesion are eligible.
- Availability of at least one record of follow-up, clinic revisit, prescription, billing settlement, or imaging assessment after administration of study drug.
- Possession of a de-identified unique identifier enabling linkage between clinical data and medical insurance settlement data.
- Fully understands this study, voluntarily participates and provides written informed consent. Data collection can only be performed after written informed consent is obtained. Waiver of informed consent is permitted if approved by the local Institutional Review Board / Independent Ethics Committee (IRB/IEC).
Who cannot join
- Patients with brain metastasis accompanied by cognitive impairment, those with concomitant neuropsychiatric disorders, a history of substance abuse, alcoholism or illicit drug use, or any other conditions that would interfere with study follow-up and outcome assessment.
- Patients with known hypersensitivity, contraindication or precautionary use to the study treatment agents, their analogues, or other biological products.
- Pregnant or lactating females.
- Patients who have participated in another interventional clinical study within 4 weeks prior to the first dose or during the study exposure period (the exposure period is defined as from the date of administration of the index study drug to 28 days after the last dose; the half-life of the index drug is approximately 7 days), and received investigational anti-tumour agents such as other anti-EGFR monoclonal antibodies or other biological targeted agents; such co-administration would prevent clear attribution of efficacy or costs within the exposure period.
- Patients with critical missing key variables, including RAS status, treatment regimen and index date, precluding the primary analysis.
- Patients deemed ineligible for enrolment for other reasons by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Medical University Union Hospital
Fuzhou, Fujian
Fenglin Chen, MD, +8613365910683, drchenflxiehe@163.com
About this study
Official title: A Real-World Study of FOLFOX Combined With Panitumumab N01 Versus Cetuximab as First-Line Treatment for RAS Wild-Type Metastatic Colorectal Cancer
This is a prospective, observational, multicenter cohort study. Subjects will be divided into the Panitumumab N01 group (experimental group) and the cetuximab or cetuximab N01 group (control group) according to the treatment they actually receive. Both groups will receive FOLFOX chemotherapy. Real-world follow-up data will be used to comprehensively evaluate clinical efficacy, safety and health economic outcomes between the two groups.
No fewer than 610 patients planned to receive first-line treatment for colorectal cancer with FOLFOX combined with Panitumumab N01 or cetuximab/cetuximab N01 will be enrolled (305 patients in the cetuximab/cetuximab N01 arm and 305 patients in the Panitumumab N01 arm). After enrollment, medical records of participants will be collected, including baseline characteristics, laboratory test results, radiological assessments, medication history and survival status, with follow-up continuing until March 2030. Adverse events will be collected up to 28 ± 7 days after the last dose to capture potential safety events. Follow-up schedule: survival will be confirmed by telephone monthly in accordance with routine clinical practice at local sites; clinical follow-up every 3 months is recommended for patients discontinuing treatment for reasons other than disease progression.
This study will not alter the established clinical decisions of treating physicians or impose additional treatment risks on patients. All treatment regimens will be administered in accordance with clinical guideline recommendations and individual patient clinical circumstances.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Panitumumab N01, Cetuximab (EGFR inhibitor)
- Keywords
- colorectal cancer, EGFR inhibitor, first line
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab N01Drug
Panitumumab N01 plus FOLFOX
Cetuximab (EGFR inhibitor)Drug
cetuximab or cetuximab N01 plus FOLFOX
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab N01 | Panitumumab N01 plus FOLFOX Receives: Drug: Panitumumab N01 | |
| Cetuximab | Cetuximab or Cetuximab N01 plus FOLFOX Receives: Drug: Cetuximab (EGFR inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Time from the index-date (initial diagnosis of RAS wild-type mCRC) to death from any cause. Patients alive or lost-to-follow-up will be censored at the date of last valid follow-up.
Measured: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death from any cause, assessed up to 30 months
Incremental Cost-Utility Ratio (ICUR)
Ratio of incremental direct medical costs versus incremental quality-adjusted life-years (QALYs) between the Panitumumab N01 arm and the cetuximab/cetuximab N01 arm; unit: CNY per QALY. Only costs generated after Panitumumab N01 is listed for national medical reimbursement are included.
Measured: From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months
Secondary outcomes (17)
2-Year Overall Survival Rate
Cumulative probability of being alive at 24 complete months after index-date, estimated by the Kaplan-Meier method. All-cause death is the event; subjects who are lost-to-follow-up or still alive before 24-month time-point are censored.
Measured: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death from any cause, assessed up to 24 months
Real-World Progression-Free Survival
Time from index-date to the earliest documented disease progression (per real-world clinical evidence: imaging, pathology, clinical notes indicating PD / new lesion) or death from any cause, whichever occurs first. Censored at last evaluable assessment for patients without events.
Measured: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of first documented disease progression or death from any cause, whichever comes first, assessed up to 30 months
Duration of Treatment
Time from first dose of study drug (Panitumumab N01 / cetuximab / cetuximab N01) to permanent discontinuation of study drug for any reason (disease progression, adverse event, patient preference, economic reason, death).
Measured: From date of first administration of study drug (panitumumab N01 or cetuximab / cetuximab N01) until date of permanent treatment discontinuation for any cause, assessed up to 30 months
Time To Next Treatment
Time from index-date to initiation of next-line systemic anti-tumor therapy or death, whichever occurs first. Maintenance therapy is not counted as next-line treatment.
Measured: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of initiation of next-line systemic anticancer therapy or death from any cause, whichever comes first, assessed up to 30 months
Objective Response Rate
Proportion of participants achieving best overall response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1, sustained for at least 4 weeks, from index-date until documented disease progression or initiation of participant's new anti-tumor therapy.
Measured: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months
Complete Response Rate
Proportion of participants achieving best overall Complete Response (CR) per RECIST 1.1, sustained for at least 4 weeks, from index-date until documented disease progression or initiation of participant's new anti-tumor therapy.
Measured: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months
Disease Control Rate
Proportion of participants achieving best overall response of CR, PR or Stable Disease (SD) per RECIST 1.1, sustained for at least 4 weeks, from index-date until documented disease progression or initiation of participant's new anti-tumor therapy
Measured: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months
Early Tumor Shrinkage Rate
Proportion of participants with ≥30 % reduction in sum of longest diameters of measurable target lesions at Week 8 ± 7 days after participant's first study-drug dose (RECIST 1.1). No minimum duration of response required.
Measured: At 8 weeks ±7 days after the participant's first study-drug dose
Depth of Response
Maximum percentage-reduction from baseline in sum of longest diameters of target lesions among participants with tumour shrinkage. Formula: (baseline sum - minimum on-treatment sum of target-lesion longest diameters) / baseline sum × 100 %.
Measured: From baseline assessment until the time point of maximum tumor shrinkage during the entire treatment period, assessed up to 30 months
Conversion Resection Rate
Percentage of participants who had MDT-confirmed initially unresectable metastatic colorectal cancer at baseline and subsequently received curative-intent resection of all primary plus metastatic lesions after receiving ≥1 cycle of study treatment.
Measured: From participant's baseline MDT assessment until completion of participant's curative-intent surgery
Cancer-Specific Survival
Time from index-date to death attributable to colorectal cancer or treatment-related complications. Deaths from other causes are treated as competing events; participants lost-to-follow-up or remaining alive are censored. Estimated via Fine-Gray competing-risk model
Measured: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death caused by colorectal cancer or its treatment-related complications, assessed up to 30 months
Treatment-Emergent Adverse Event (TEAE) Incidence
Proportion of participants experiencing at least one TEAE (any adverse event newly occurring or worsening from first study-drug dose through 28 days ± 7 days after last study-drug dose), graded per CTCAE 6.0.
Measured: From participant's first study-drug dose to 28 days ± 7 days after participant's last study-drug dose
Per-Patient Full-Cycle Direct Medical Costs
Per-participant total direct anti-tumour-related medical costs from index-date to death, including targeted-drug cost, chemotherapy cost, pre-medication cost, adjunctive-drug cost, lab-imaging costs, inpatient costs, outpatient costs and adverse-event-management costs.
Measured: From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months
Per-Patient Medical-Insurance-Fund Payment Amount
Per-participant total amount paid by medical-insurance funds (pooling fund, catastrophic-insurance, medical-assistance, supplementary-enterprise-insurance)
Measured: From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months
EQ-5D-5L Health-Utility Value
Health-state utility value derived from the Chinese EQ-5D-5L value set, covering mobility, self-care, usual-activities, pain-discomfort, anxiety-depression; score range -0.594 ~ 1.0 (1 = full health, 0 = death; negative values represent states worse-than-death).
Measured: Assessed at baseline, weekly for the first 2 months of treatment, every 3 months (±7 days) during subsequent treatment, and every 6 months (±14 days) after disease progression, through study completion, up to 30 months
FACT-EGFRI-18
Patient-reported 18-item FACT-EGFRI-18 questionnaire evaluating EGFR-inhibitor-associated physical, social-family and functional symptom burden over the prior 7 days; total score and sub-domain scores (physical well-being, social-family well-being, functional well-being). Higher scores represent lower symptom burden and better quality-of-life
Measured: At baseline within 28 days before the participant's first study-drug dose; weekly for the first 2 months of the participant's treatment; every 3 months ± 7 days thereafter; up to 28 days ± 7 days after the participant's last study-drug dose
PRO-CTCAE Adverse-Event Outcomes
Patient-reported adverse-event frequency and severity collected via PRO-CTCAE questionnaire over prior 7 days. Endpoints include overall AE incidence, frequency-grade distribution and severity-grade distribution of individual symptoms.
Measured: At participant's baseline; weekly for the first 2 months of the participant's treatment; every 3 months ± 7 days thereafter; up to 28 days ± 7 days after the participant's last study-drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 610 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Fenglin, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917429
- Sponsor's protocol ID
- QL-CRC-ANKZ-3009
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. This study uses de-identified clinical and medical insurance settlement data. Data sharing is prohibited by local data security and medical privacy regulations
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of FOLFOX Combined With Panitumumab N01 Versus Cetuximab as First-Line Treatment for RAS Wild-Type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07917429
- Acronym / sponsor ID
- QL-CRC-ANKZ-3009
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- colorectal cancer, EGFR inhibitor, first line
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, observational, multicenter cohort study. Subjects will be divided into the Panitumumab N01 group (experimental group) and the cetuximab or cetuximab N01 group (control group) according to the treatment they actually receive. Both groups will receive FOLFOX chemotherapy. Real-world follow-up data will be used to comprehensively evaluate clinical efficacy, safety and health economic outcomes between the two groups.
No fewer than 610 patients planned to receive first-line treatment for colorectal cancer with FOLFOX combined with Panitumumab N01 or cetuximab/cetuximab N01 will be enrolled (305 patients in the cetuximab/cetuximab N01 arm and 305 patients in the Panitumumab N01 arm). After enrollment, medical records of participants will be collected, including baseline characteristics, laboratory test results, radiological assessments, medication history and survival status, with follow-up continuing until March 2030. Adverse events will be collected up to 28 ± 7 days after the last dose to capture potential safety events. Follow-up schedule: survival will be confirmed by telephone monthly in accordance with routine clinical practice at local sites; clinical follow-up every 3 months is recommended for patients discontinuing treatment for reasons other than disease progression.
This study will not alter the established clinical decisions of treating physicians or impose additional treatment risks on patients. All treatment regimens will be administered in accordance with clinical guideline recommendations and individual patient clinical circumstances.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panitumumab N01 | – | Drug: Panitumumab N01Panitumumab N01 plus FOLFOX |
| Cetuximab | – | Drug: Cetuximab (EGFR inhibitor)Cetuximab or Cetuximab N01 plus FOLFOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First-line RAS wild-type metastatic colorectal cancer patients
Key inclusion criteria (7 listed)
- Aged ≥ 18 years, regardless of gender.
- Histopathologically and radiologically-confirmed metastatic colorectal cancer with RAS wild-type status (wild-type for KRAS and NRAS exons 2, 3 and 4; if test records are limited, the exact test scope and testing method should be documented); and the participant is planned to receive FOLFOX combined with either Panitumumab N01 or cetuximab/cetuximab N01.
- At least one measurable lesion assessable per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- No prior anti-tumor therapy for colorectal cancer, including chemotherapy, radiotherapy, targeted agents, surgery and immunotherapy. Participants with disease recurrence and metastasis > 3 months after completion of adjuvant chemotherapy or prior local treatment of the primary lesion are eligible.
- Availability of at least one record of follow-up, clinic revisit, prescription, billing settlement, or imaging assessment after administration of study drug.
Key exclusion criteria (6 listed)
- Patients with brain metastasis accompanied by cognitive impairment, those with concomitant neuropsychiatric disorders, a history of substance abuse, alcoholism or illicit drug use, or any other conditions that would interfere with study follow-up and outcome assessment.
- Patients with known hypersensitivity, contraindication or precautionary use to the study treatment agents, their analogues, or other biological products.
- Pregnant or lactating females.
- Patients who have participated in another interventional clinical study within 4 weeks prior to the first dose or during the study exposure period (the exposure period is defined as from the date of administration of the index study drug to 28 days after the last dose; the half-life of the index drug is approximately 7 days), and received investigational anti-tumour agents such as other anti-EGFR monoclonal antibodies or other biological targeted agents; such co-administration would prevent clear attribution of efficacy or costs within the exposure period.
- Patients with critical missing key variables, including RAS status, treatment regimen and index date, precluding the primary analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panitumumab N01Panitumumab N01 plus FOLFOX | Drug | Panitumumab N01 |
| Cetuximab (EGFR inhibitor)cetuximab or cetuximab N01 plus FOLFOX | Drug | Cetuximab |
Primary outcome
overall survival
Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death from any cause, assessed up to 30 months
Time from the index-date (initial diagnosis of RAS wild-type mCRC) to death from any cause. Patients alive or lost-to-follow-up will be censored at the date of last valid follow-up.
Incremental Cost-Utility Ratio (ICUR)
Time frame: From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months
Ratio of incremental direct medical costs versus incremental quality-adjusted life-years (QALYs) between the Panitumumab N01 arm and the cetuximab/cetuximab N01 arm; unit: CNY per QALY. Only costs generated after Panitumumab N01 is listed for national medical reimbursement are included.
17 secondary outcomes
2-Year Overall Survival Rate
Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death from any cause, assessed up to 24 months
Real-World Progression-Free Survival
Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of first documented disease progression or death from any cause, whichever comes first, assessed up to 30 months
Duration of Treatment
Time frame: From date of first administration of study drug (panitumumab N01 or cetuximab / cetuximab N01) until date of permanent treatment discontinuation for any cause, assessed up to 30 months
Time To Next Treatment
Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of initiation of next-line systemic anticancer therapy or death from any cause, whichever comes first, assessed up to 30 months
Objective Response Rate
Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months
Complete Response Rate
Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months
Disease Control Rate
Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months
Early Tumor Shrinkage Rate
Time frame: At 8 weeks ±7 days after the participant's first study-drug dose
Depth of Response
Time frame: From baseline assessment until the time point of maximum tumor shrinkage during the entire treatment period, assessed up to 30 months
Conversion Resection Rate
Time frame: From participant's baseline MDT assessment until completion of participant's curative-intent surgery
Cancer-Specific Survival
Time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death caused by colorectal cancer or its treatment-related complications, assessed up to 30 months
Treatment-Emergent Adverse Event (TEAE) Incidence
Time frame: From participant's first study-drug dose to 28 days ± 7 days after participant's last study-drug dose
Per-Patient Full-Cycle Direct Medical Costs
Time frame: From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months
Per-Patient Medical-Insurance-Fund Payment Amount
Time frame: From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months
EQ-5D-5L Health-Utility Value
Time frame: Assessed at baseline, weekly for the first 2 months of treatment, every 3 months (±7 days) during subsequent treatment, and every 6 months (±14 days) after disease progression, through study completion, up to 30 months
FACT-EGFRI-18
Time frame: At baseline within 28 days before the participant's first study-drug dose; weekly for the first 2 months of the participant's treatment; every 3 months ± 7 days thereafter; up to 28 days ± 7 days after the participant's last study-drug dose
PRO-CTCAE Adverse-Event Outcomes
Time frame: At participant's baseline; weekly for the first 2 months of the participant's treatment; every 3 months ± 7 days thereafter; up to 28 days ± 7 days after the participant's last study-drug dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This study uses de-identified clinical and medical insurance settlement data. Data sharing is prohibited by local data security and medical privacy regulations
Related trials for Colorectal Cancer Metastatic
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fenglin Chen, MD (+8613365910683, drchenflxiehe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death from any cause, assessed up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.